- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01100073
Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
perjantai 14. maaliskuuta 2014 päivittänyt: Boehringer Ingelheim
The study will compare the effect of pramipexole on different types of tremor and particularly kinetic tremor in early and advanced Parkinson's disease patients and will evaluate the course of tremor measured with spiralometry under pramipexole treatment.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Todellinen)
1703
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Kuldiga, Latvia
- Boehringer Ingelheim Investigational Site 9
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Liepaja, Latvia
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Liepaja, Latvia
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Liepaja, Latvia
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Liepaja, Latvia
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Limbazi, Latvia
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Limbazi, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Riga, Latvia
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Aiud, Romania
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Arges, Romania
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Arges, Romania
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Arges, Romania
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Arges, Romania
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Arges, Romania
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Arges, Romania
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Arges, Romania
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Bacau, Romania
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Bacau, Romania
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Bistrita, Romania
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Botosani, Romania
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Botosani, Romania
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Braila, Romania
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Braila, Romania
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Brasov, Romania
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Brasov, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Bucuresti, Romania
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Buzau, Romania
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Buzau, Romania
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Caracal, Romania
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Cluj, Romania
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Cluj, Romania
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Cluj, Romania
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Cluj, Romania
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Cluj, Romania
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Cluj, Romania
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Constanta, Romania
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Constanta, Romania
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Craiova, Romania
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Craiova, Romania
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Craiova, Romania
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Craiova, Romania
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Deva, Romania
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Deva, Romania
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Focsani, Romania
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Focsani, Romania
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Galati, Romania
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Galati, Romania
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Hunedoara, Romania
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Hunedoara, Romania
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Iasi, Romania
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Iasi, Romania
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Iasi, Romania
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Iasi, Romania
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Lugoj, Romania
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Maramures, Romania
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Orastie, Romania
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Pascani, Romania
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Pascani, Romania
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Petrosani, Romania
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Piatra Neamt, Romania
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Prahova, Romania
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Prahova, Romania
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Prahova, Romania
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Radauti, Romania
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Resita, Romania
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Satu Mare, Romania
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Sibiu, Romania
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Sibiu, Romania
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Slatina, Romania
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Suceava, Romania
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Suceava, Romania
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Teleorman, Romania
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Tg. Mures, Romania
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Timisoara, Romania
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Timisoara, Romania
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Timisoara, Romania
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Timisoara, Romania
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Tulcea, Romania
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Tulcea, Romania
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Belgrade, Serbia
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Belgrade, Serbia
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Kragujevac, Serbia
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Krusevac, Serbia
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Nis, Serbia
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Nis, Serbia
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Novi Sad, Serbia
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Sombor, Serbia
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Uzice, Serbia
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Valjevo, Serbia
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Vranje, Serbia
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Banská Bystrica, Slovakia
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Bardejov, Slovakia
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Bratislava, Slovakia
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Bratislava, Slovakia
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Bratislava, Slovakia
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Bratislava, Slovakia
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Bratislava, Slovakia
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Bratislava, Slovakia
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Brezno, Slovakia
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Humenné, Slovakia
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Ilava, Slovakia
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Komárno, Slovakia
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Kosice, Slovakia
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Kosice, Slovakia
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Kosice, Slovakia
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Kosice, Slovakia
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Kosice- Saca, Slovakia
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Krompachy, Slovakia
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Levice, Slovakia
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Liptovský Mikulás, Slovakia
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Lucenec, Slovakia
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Martin, Slovakia
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Nitra, Slovakia
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Nitra, Slovakia
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Nitra, Slovakia
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Nováky, Slovakia
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Nové Mesto n/ Váhom, Slovakia
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Pezinok, Slovakia
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Pies?any, Slovakia
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Povazská Bystrica, Slovakia
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Presov, Slovakia
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Presov, Slovakia
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Presov, Slovakia
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Revúca, Slovakia
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Rimavská Sobota, Slovakia
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Roznava, Slovakia
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Roznava, Slovakia
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Sal'a, Slovakia
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Sered, Slovakia
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Skalica, Slovakia
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Stropkov, Slovakia
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Surany, Slovakia
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Trebisov, Slovakia
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Tren?in, Slovakia
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Trnava, Slovakia
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Trnava, Slovakia
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Trstená, Slovakia
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Vel'ke Kapusany, Slovakia
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Zilina, Slovakia
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Zilina, Slovakia
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Zlaté Moravce, Slovakia
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Maribor, Slovenia
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Maribor, Slovenia
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Maribor, Slovenia
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Sempeter pri Gorici, Slovenia
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Kyiv, Ukraina
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Lviv, Ukraina
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Moscow, Venäjän federaatio
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Moscow, Venäjän federaatio
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Näytteenottomenetelmä
Ei-todennäköisyysnäyte
Tutkimusväestö
Neurologists
Kuvaus
Inclusion Criteria:
- Idiopathic Parkinson's disease with or without fluctuations
- Indication for treatment with pramipexole (Mirapexin®)
- Presence of at least mild tremor symptoms (as judged by the treating physician)
Exclusion Criteria:
- Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
- Ongoing treatment with pramipexole (Mirapexin®)
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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Patients with Parkinson's disease
Early and advanced Parkinson's disease patients
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance
Aikaikkuna: Week 0 to weeks 9-16 (Visit 3)
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Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study.
Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
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Week 0 to weeks 9-16 (Visit 3)
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Change From Baseline in UPDRS Part III Score at the End of Maintenance
Aikaikkuna: Week 0 to weeks 9-16
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Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study.
Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
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Week 0 to weeks 9-16
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Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)
Aikaikkuna: Week 0 to weeks 9-16 (Visit 3)
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Change (reduction) in tremor amplitude from baseline to end of study for the right hand
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Week 0 to weeks 9-16 (Visit 3)
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Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)
Aikaikkuna: Week 0 to weeks 9-16 (Visit 3)
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Change (reduction) in tremor amplitude from baseline to end of study for the left hand
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Week 0 to weeks 9-16 (Visit 3)
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Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)
Aikaikkuna: Week 0 to weeks 9-16 (Visit 3)
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Change (reduction)in tremor score from baseline to end of study.
Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
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Week 0 to weeks 9-16 (Visit 3)
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Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance
Aikaikkuna: Week 0 to weeks 9-16 (Visit 3)
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Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study.
Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure)
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Week 0 to weeks 9-16 (Visit 3)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Final Dose Distribution
Aikaikkuna: Enter Week 0 to weeks 9-16 (Visit 3)
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Final Mirapexin® dose distribution at the end of study
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Enter Week 0 to weeks 9-16 (Visit 3)
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Change From Baseline in UPDRS Part II Score at the End of Up-titration
Aikaikkuna: Enter Week 0 to weeks 1-8 (Visit 2)
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Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to Visit 2. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
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Enter Week 0 to weeks 1-8 (Visit 2)
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Change From Baseline in UPDRS Part III Score at the End of Up-titration
Aikaikkuna: Enter Week 0 to weeks 1-8 (Visit 2)
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Change (reduction) in UPDRS Part III score (motor function) from baseline to Visit 2. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
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Enter Week 0 to weeks 1-8 (Visit 2)
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Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration
Aikaikkuna: Enter Week 0 to weeks 1-8 (Visit 2)
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Change (reduction) from baseline in tremor score, derived from UPDRS from baseline to Visit 2. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
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Enter Week 0 to weeks 1-8 (Visit 2)
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Incidence, Relationship and Seriousness of Adverse Events
Aikaikkuna: Week 0 to weeks 9-16 (end of study)
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Total number of adverse events (AEs), causality and level of seriousness
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Week 0 to weeks 9-16 (end of study)
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Number of Premature Discontinuations
Aikaikkuna: Week 0 to weeks 9-16 (end of study)
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Number of patients discontinuing the study prematurely
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Week 0 to weeks 9-16 (end of study)
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Perjantai 1. helmikuuta 2008
Ensisijainen valmistuminen (Todellinen)
Lauantai 1. elokuuta 2009
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 18. maaliskuuta 2010
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 7. huhtikuuta 2010
Ensimmäinen Lähetetty (Arvio)
Torstai 8. huhtikuuta 2010
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Perjantai 11. huhtikuuta 2014
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 14. maaliskuuta 2014
Viimeksi vahvistettu
Lauantai 1. maaliskuuta 2014
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 248.657
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .